Using Mobile Technology to Better Understand and Measure Self-Regulation

Completed · Not applicable

Conditions studied: Self-regulation, Binge Eating, Smoking

In brief

This study will evaluate the extent to which we can engage and manipulate putative targets within the self-regulation domain outside of laboratory settings in samples of smokers and overweight/obese individuals with binge eating disorder. Fifty smokers and 50 overweight/obese individuals with binge eating disorder will be recruited to participate in a non-lab experimental paradigm in which we will leverage our novel mobile behavioral assessment/intervention technology platform. We will measure and modulate engagement of potential self-regulation targets and collect data in real time and in real-world conditions. Mobile sensing will be added to up to 50 additional participants.

Key facts

Study ID: NCT03352713
Run by: Dartmouth-Hitchcock Medical Center
People needed: 185
Starts: 2018-01-11
Expected to finish: 2018-12-03
Last updated by the study team: 2020-01-10

Who can join

Age: 21 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 21-50 years
Understand English sufficiently to provide informed consent
Use a smartphone (participants without mobile sensing); proficient with using smartphone and comfort wearing devices (participants with mobile sensing)
Additional inclusion criteria for binge eating sample:
27 ≤ BMI ≤ 45 kg/m2
Have binge eating disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria
Non-smoking (defined as no cigarettes in past 12 months-this includes former and never smokers)
Additional inclusion criteria for smoking sample:
Smoke 5 or more tobacco cigarettes/day for past year
17 ≤ BMI < 27 kg/m2

You may not qualify if…

Any current substance use disorder
o Will not exclude based on use of substances
Currently pregnant or plans to become pregnant in next 3 months
Lifetime history of major psychotic disorders (including schizophrenia and bipolar disorder)
Current use of any medication for psychiatric reasons (including stimulants and mood stabilizers)
Current use of prescription pain medications (e.g., Vicodin, oxycodone)
Current use of any medication for smoking
Exceptions: short-acting nicotine replacement therapy (e.g., gum, lozenge, nasal spray, inhaler)
Will screen out for Wellbutrin or varenicline
Current use of any medication for weight loss
Have undergone weight-loss surgery (e.g., gastric bypass, lap band)
Current nighttime shift work or obstructive sleep apnea
Note: We will not exclude based on e-cigarette use.
Additional exclusion criteria for binge eating sample:
Compensatory behavior (e.g., purging, excessive exercise, fasting) [already excluded as part of the DSM-5 binge eating disorder criteria]
Lost weight in recent past (>10 pounds in past 6 months)
Currently in a weight-loss program (e.g., Weight Watchers, Jenny Craig) [will not exclude on online/mobile app weight-loss programs]
Currently on a special diet for a serious health condition
Additional exclusion criteria for smoking sample:
Binge eating behavior according to Questionnaire on Eating and Weight Patterns-5 (QEWP-5) ("yes" to Qs 8 and 9 and for Q10, at least one episode per week for three months).
- QEWP-5 #8: During the past three months, did you ever eat in a short period of time (for example, a two-hour period) what most people would think was an unusually large amount of food? [yes or no]
- QEWP-5 #9: During the times when you ate an unusually large amount of food, did you ever feel you could not stop eating or control what or how much you were eating? [yes or no]
- QEWP-5 #10: During the past three months, how often, on average, did you have episodes like this? That is, eating large amounts of food plus the feeling that your eating was out of control? (There may have been some weeks when this did not happen. Just average those in.) [less than one episode per week, five response options for 1 or more episodes per week]

Where it is running

Center for Technology and Behavioral Health, Dartmouth College — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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